Kornimate/medical-research-clean huggingface dataset:
raltegravir (isentress/mk-0518) and hiv-1 infected cd4 cells during acute/early hiv-1

Conditions: Human Immunodeficiency Virus

Summary: this is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (haart) to 3-drug haart plus raltegravir for persons with acute and early hiv-1 infection. the study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg bid orally) to inhibit the integration step of the hiv-1 life cycle in conjunction with haart in subjects with recently acquired hiv-1 infection will decrease the number of hiv-1 infected cd4+ t-cells to a greater extent than a 3-drug haart regimen.

the study will be conducted at the uw primary infection clinic and the uw aids clinical trials unit. secondary objectives will characterize safety, tolerability, plasma hiv-1 rna and cd4+ t-cell values. the 3-drug haart will be chosen and provided by the subject.

Eligibility criteria:
inclusion criteria: * acute or early hiv-1 infection * hiv-1 rna \> or equal to 500 copies/ml * acceptable safety lab results (specified in protocol) * negative pregnancy test for females * willingness to use contraception (for females of reproductive potential exclusion criteria: * prior receipt of investigational hiv-1 vaccine * use of immunomodulators other than systemic steroids within 30 days before entry * serious medical or psychiatric illness that would interfere with study participation * active drug or alcohol use that would interfere with study participation * allergy/hypersensitivity to raltegravir * pre- or post-exposure prophylaxis for the exposure that led to hiv-1 acquisition * pregnancy or breastfeeding * history of malignancy (other than localized squamous cell or basal cell cancer of the skin)

Keywords: human immunodeficiency virus raltegravir primary hiv infection hiv-1
pk/pd of extended-infusion meropenem, piperacillin-tazobactam and cefepime in the early phase of septic shock

Conditions: Septic Shock

Summary: this study evaluates pk/pd of an extended-infusion protocol of meropenem, piperacillin-tazobactam and cefepime, in the early phase of septic shock.

beta lactams are the keystones of shock septic treatment. early phase of septic shock is a period of disturbed pharmacokinetics, with augmented renal clearance and distribution volume of hydrophilic drugs as beta lactams. consequently, early phase of septic shock is a period at risk of underdosing beta lactam, which could increase the risk of clinical failure an mortality. data are available concerning underdosing of meropenem, piperacillin-tazobactam and cefepime, when administered in bolus. no data exist concerning the achievement of a target of 100% of the whole interval above 4 time the superior breakpoint of pseudomonas aeruginosa according to eucast (european committee on antimicrobial susceptibility testing), during the 48 first hours of treatment of septic shock, when beta lactam are administered in extended infusion.

Eligibility criteria:
inclusion criteria: * septic shock * meropenem, piperacillin-tazobactam or cefepime started after enrollment exclusion criteria: * pregnancy * central nervous system infection * burns

Keywords: septic shock, beta lactams, extended infusion, pk/pd
evaluation of oral thc and cbd in men and women

Conditions: Drug Abuse; Intoxication by Drug; Impairment

Summary: the purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (thc) and cannabidiol (cbd) and to evaluate detection of recently smoked thc in oral fluid.

this double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent thc or cbd use. other pharmacodynamic effects of oral thc or cbd will be determined and the pharmacokinetics of thc, cbd, and respective metabolites will be assessed in whole blood.

Eligibility criteria:
inclusion criteria: * male or non-pregnant and non-lactating females aged 21-55 years * report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening, * not currently seeking treatment for their cannabis use * have a body mass index from 18.5 - 34kg/m2. * able to perform all study procedures * must be using a contraceptive (hormonal or barrier methods) exclusion criteria: * meeting dsm-v criteria for moderate to severe cannabis use disorder (cud) or any substance use disorder other than nicotine, caffeine * any other axis i disorder * report using other illicit drugs in the prior 4 weeks, other than cannabis. * current use of any medications that may affect study outcomes * if medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures. * pregnancy is exclusionary due to the possible effects of the study medication on fetal development. * history of an allergic reaction or adverse reaction to cannabis is exclusionary. * history of respiratory illness or current respiratory illness * currently enrolled in another research protocol * not using a contraceptive method (hormonal or barrier methods) * the evaluating physician reviews all medical assessments along with medical history. any disorders that might make cannabis administration hazardous are exclusionary.

Keywords: thc cbd intoxication impairment
defining outcome measures for behavioural and emotional problems in dystrophinopathies

Conditions: DMD; BMD

Summary: study aims to develop and to evaluate the neurophysiological and physiological response to a classical conditioning task.to better understand how duchenne muscular dystrophy (dmd) and becker muscular dystrophy (bmd) impacts mental health and how to assess it. participants invited to complete questionnaires about behaviour, cognitive function and social interactions, complete computer tasks and have an optional mri brain scan,

the investigation aims to develop and to evaluate the neurophysiological and physiological response to a classical conditioning task, which is comparable to findings that have been made in the mdx dystrophic mouse (deficient in dp427). the investigators will assess correlations between the specific dmd/bmd genotype and susceptibility to conditioning, as well as the relationship between conditioning and behavioural/emotional characteristics of the syndrome. at the end of the study, the objective is to deliver a comprehensive test battery that is suitable for use in a trial of aon delivery to improve brain function.

Eligibility criteria:
inclusion criteria: * dmd patients: 1. male 2. age range 7-17 years 3. a genetically proven diagnosis of dmd. 4. a genetic mutation that abrogates expression of dp427 alone (assigned in dmd group 1: dp427-/dp140+) or both dp427 and dp140 (assigned to dmd group 2: dp427-/dp140-). 5. ability to consent/assent bmd patients: 1. male 2. age range 7-17 years 3. a genetically proven diagnosis of bmd. 4. a genetic mutation that decreases expression of dp427 alone (assigned to bmd group 1), of both dp427 and dp140 (assigned to bmd group 2). 5. ability to consent/assent control participants: 1. male 2. age range 7-17 years. 3. ability to consent/assent exclusion criteria: * dmd \& bmd patients: 1. significant visual or hearing impairment 2. specific phobias or sensory sensitivities to stimuli similar to the ones used in this study 3. current participation in a clinical trial investigating a new drug involved in dystrophin modulation. 4. inability to consent (for parents/guardians or self-reporting participants aged 16 and 17) or assent. this will exclude the rare individuals with extremely severe learning disability, as the assent in these patients is impossible (or the consent in self-reporting participants aged 16 and 17). control participants: 1. significant visual or hearing impairment 2. specific phobias or sensory sensitivities to stimuli similar to the ones used in this study 3. any diagnosis of neurological or psychiatric condition general exclusion criteria for mri: 1. claustrophobia 2. pacemakers and defibrillators 3. nerve stimulators 4. intracranial clips 5. intraorbital or intraocular metallic fragments 6. cochlear implants 7. ferromagnetic implants (e.g. thoracic implant for scoliosis) 8. inability to lie supine during less than 45 minutes 9. not having a general practitioner 10. severe learning disability which will require a general anaesthetic

Keywords: antisense oligonucleotide
clinical retention of glass ionomer sealants placed with and without rubber dam: a comparative analysis

Conditions: Dental Caries in Children

Summary: a comparative analysis of glass ionomer sealant placed on permanent molars with and without a rubber dam to assess the retention over a 2 year period.

the purpose of the study is to compare the retention rates of glass ionomer sealants placed on first permanent molars over a period of 2 years. pediatric patients (under \<10 years of age) will receive a glass ionomer sealant on all four permanent first molars. one side will be randomly selected with rubber dam isolation and the contralateral side will have no rubber dam isolation for the placement of the sealant. over a 2 year period, every 6 months the sealants will be assessed for retention. the glass ionomer sealant material will be fuji triage (gc america). the following dental materials that will be used are cotton rolls, non-latex rubber dam, topical benzocaine, dental mirror, glass ionomer dispensing gun, dental explorer, triturator for the glass ionomer, cotton gauze, suction tip, air-water syringe.

Eligibility criteria:
inclusion criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects. - exclusion criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects, -
comparison of laparoscopic herniotomy and open herniotomy in children

Conditions: Inguinal Hernia

Summary: all patients of age 6 month to 12 years with inguinal hernia were included in study. data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications

background: the best method of inguinal hernia repair in children continues to be a topic of debate. although recent data shows that lpec is superior and safe but no such data exists in our country. operative time and recurrence are main concerns. hence, present study is carried out to compare outcome of lpec versus ohr in children. objective: to compare the outcome of laparoscopic percutaneous extra-peritoneal closure and open repair for inguinal hernia in children methodology: it was a randomized control trial conducted on 66 patients (33 in each group) presented to our hospital with features of inguinal hernia. patients were admitted after confirmation of diagnosis by ultrasound and complete blood count (cbc) was sent. pre operatively patients were divided in two groups randomly (open hernia repair group, lpec group) by closed envelope method. consent was taken from parents regarding inclusion in the study. all demographic data and results were noted down in a proforma. the collected data was entered and analyzed in computer software spss (statistical package for social sciences) version 26.0.

Eligibility criteria:
inclusion criteria: all patients of age 6 months to 12 years of either gender having unilateral or bilateral inguinal hernia diagnosed on history, clinical examination and investigations. exclusion criteria: 1. patients with recurrent inguinal hernia, hydrocele, hernia with undescended testes and sliding hernia diagnosed on history, clinical examination and investigations. 2. patients with complicated hernia (e.g. incarcerated ovary), irreducible or obstructed inguinal hernia diagnosed on history, clinical examination and investigations. 3. patients who cannot tolerate pneumoperitoneum or general anaesthesia. 4. patients with congenital heart disease, other co-morbid conditions. -

Keywords: laparoscopic herniotomy open herniotomy, inguinal hernia children
effects of desoximetasone spray 0.25% on moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: efficacy study in patients with moderate to severe plaque psoriasis.

a double-blind, vehicle-controlled, randomized, parallel design, multiple-site clinical study to evaluate the efficacy and safety of desoximetasone 0.25% topical spray in patients with moderate to severe plaque psoriasis

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female 18 years of age or older. * have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (bsa). * have a combined total lesion severity score (tlss) of ≥ 7 for the target lesion. * have a plaque elevation score ≥ 3 of (moderate) for the target lesion. * the target lesion must have an area of at least 5 cm². * have a physicians global assessment (pga) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity. exclusion criteria: * patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp. * patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy. * in the investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis. * patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the patient or the results of the study. * patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. * patient has received any systemic steroids within 4 weeks of the first dose of the study drug. the use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study. * patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study. * receipt of any drug as part of a research study within 30 days prior to first dosing.
prophylactic mesh placement during stoma closure after low anterior resection

Conditions: Neoplasms Malignant; Rectal Cancer; Hernia Incisional; Surgery

Summary: the goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. the main question it aims to answer is: can mesh help prevent hernia? participants will be divided into 2 groups: with and without mesh using. they must be followed up for 2 years after enrollment in the study. researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.

this clinical trial is prospective randomized phase iii study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. we will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. in these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. stratification will be used for patients with \>5 cm vs \<5 cm stoma-site hernia. the control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation. additional endpoints are the wound infection rate, the complication rate (clavien-dindo), the rate of the repeated surgery for hernia at the site of stoma closure. we'll assess the quality of life by herqles (hernia-related quality of life survey) scale.

Eligibility criteria:
inclusion criteria: * signed informed consent * absence of distant metastases (m0) * ecog (eastern cooperative oncology group) status 0-2 * completed course of adjuvant treatment * absence of acute inflammatory parastomal complications * integrity of colorectal anastomosis exclusion criteria: * inability to obtain consent to participate * synchronous and metachronous malignant neoplasms * clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system * parastomal inflammation and other conditions that increase the risk of postoperative complications * pregnancy * hiv infection

Keywords: rectal cancer mesh stoma-site hernia prevention surgery
caring relationships expression study

Conditions: Caregiver Burden; Anxiety; Stress

Summary: this study will examine a heart rate variability biofeedback (hrvb) intervention versus a music listening control (mlc) for 30 family caregivers (fcgs) of alzheimer's disease (ad) (and related dementias: adrd) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality over the course of 8-weeks.

this pilot study aims to examine feasibility of implementing a hrvb intervention and an mlc control with ad fcgs. the hrvb and mlc interventions will be evaluated for acceptability (operationalized as adherence to intervention) and satisfaction and to identify necessary intervention modifications. feasibility benchmarks: 85% of participants will be at least 70% adherent to implementation goals (10-min use 5-7 days per week). feasibility of randomization will be examined by comparing adherence/retention (expecting similar patterns across interventions). acceptability/satisfaction with hrvb and mlc will be evaluated in semi-structured interviews post-intervention including detailed probing on feature preferences, barriers/facilitators, suggested improvements for retention. the second aim of this study is to examine patterns of association of hrvb and mlc with outcomes. the investigators will examine pre- to post-intervention changes (and sustained outcomes at follow-up) in self-reported caregiver burden, stress and resilience. change in relationship quality will additionally be assessed from pre- to post intervention. change in ans balance, a neurophysiological indicator of reduced emotional distress and improved resilience, will be assessed using hrv data at all four timepoints to examine trends and change over time. significance tests will not be conducted, in alignment with goals for pilot feasibility studies. the investigators will observe the direction of change and outcomes to examine the value of mlc as an appropriate control condition showing minimal placebo effects compared to hrvb.

Eligibility criteria:
inclusion criteria: * in primary/unpaid fcg role \> 6 months * caring for mild-to-severe adrd patient * 4 caregiver burden score own/operate smartphone w data plan exclusion criteria: * pacemakers or implanted cardioconverter defibrillator (icd), or conditions/meds that interfere with hrv measurement/feedback

Keywords: heart rate variability biofeedback alzheimer's disease dementia
a small clinical study: photodynamic therapy to treat hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: this study will investigate the efficacy of photodynamic therapy (pdt), which is the therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (hs), a chronic inflammatory condition affecting areas of skin with sweat glands. we expect that pdt is effective in treating hs.

this study will investigate the efficacy of pdt using aminolevulinic acid (ala) and either blue light or intense pulsed light on active lesions of hs. we will attempt to validate the success noted in a previously published case series using pdt with ala and blue light (gold, bridges et al). we will evaluate effect of treatment by number of lesions, global disease severity, and patient self-assessment with the dermatology life quality index (dlqi). detailed informed consent will be obtained prior to treatment at study enrollment. the first four treatment visits will involve clinical evaluation, photography and application of the ala to the affected area. after a 45 minute incubation period, the area will be washed and then treated with either blue light or intense pulsed light (ipl), depending on body area/investigator choice. one and three-month follow-up visits will involve evaluation of efficacy, but no active treatment. gold m, bridges tm, et al. ala-pdt and blue light therapy for hidradenitis suppurative. j drugs dermatol. 2004; 3 (1 suppl):s32-5.

Eligibility criteria:
inclusion criteria: * multiple lesions consistent with hs in axillae/groin * history of no or poor response to at least one treatment modality * no active treatment in the 2 weeks prior to study initiation exclusion criteria: * pregnancy/lactation * photosensitizing drug use within 30 days of start of study * active infection needing antibiotics * history of porphyria or photosensitivity